Brief Summary of Indications, Contraindications, and warnings for the PRESTIGE® Cervical Disc
The PRESTIGE® Cervical Disc is indicated in skeletally mature patients for reconstruction of the disc from levels C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The PRESTIGE® device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy should present with at least one of the following items producing symptomatic nerve root and/or spinal cord compression which is documented by patient history (e.g., pain [neck and/or arm pain], functional deficit, and/or neurological deficit), and radiographic studies (e.g., CT, MRI, x-rays, etc.): 1) herniated disc, and/or 2) osteophyte formation.
The PRESTIGE® Cervical Disc should not be implanted in patients with an active infection or with an allergy to stainless steel.
The PRESTIGE® Cervical Disc should only be used by surgeons who are experienced in the surgical procedure and have undergone adequate training with the device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, such as neurological complications.
The safety and effectiveness of this device has not been established in patients with the following conditions: more than one cervical level with DDD; not skeletally mature; clinically significant cervical instability; prior fusion at adjacent cervical level; severe facet joint pathology of involved vertebral bodies; prior surgery at treated level; osteopenia, osteomalacia, or osteoporosis as defined by bone mineral density T-score of -3.5, or -2.5 with vertebral crush fracture; spinal metastases; chronic or acute renal failure or history of renal disease; taking medications known to potentially interfere with bone/soft tissue healing (e.g. steroids); pregnant; cervical instability; severe insulin dependent diabetes; and were not refractory to at least six weeks of unsuccessful conservative treatment or had signs of progression or spinal cord/nerve root compression with continued non-operative care.
Implanted metal alloys release metallic ions into the body (especially those devices with metal-on-metal articulating surfaces). The long term effect of these ions on the body is not known.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician with appropriate training or experience.
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
It is important that you discuss the potential risks, complications, and benefits of PRESTIGE® CERVICAL DISC with your doctor prior to receiving treatment, and that you rely on your physician's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.